The SKOAP Study
The SKOAP Study is a large national study of treatments for knee pain and will involve veterans, active military, as well as the general public.
Purpose
The purpose of the SKOAP Study is to compare different treatments for people living with knee osteoarthritis. The goal is to reduce pain and improve function using conservative treatments and, if needed, non-surgical procedural treatments that have been shown to reduce pain.
Process
This study has two phases, and both phases compare different non-surgical treatments for knee osteoarthritis pain.
Phase 1 Study Activities
Pre-Intervention Visit
Virtual or in-person visit
- Medical history
- A physical examination focused on the knee
- Reviewing of medical records and medications
- Check for recent knee X-ray
- Complete questionnaires
- Randomization into treatment arm
2-Week Phone Call
Remote phone call
For participants prescribed duloxetine during baseline:
- Phone call with research staff or research nurse to discuss medication and decrease or increase medication as needed
4-Week and 8-Week Follow-Up
Call with a study team member
(in-person visit if needed)
- Questionnaires
- Review of study medication (if applicable)
- Assessment of best practices
(other activities/treatment)
Monthly Follow-Up
For participants that are satisfied with their Phase 1 treatment
- Maintain current Phase 1 treatment
- Monthly follow-up for up to 24 months
- Can be done via brief survey or by phone
Phase 1 Treatments
People who participate in Phase 1 are randomized to one of three groups:
1. Best Practices: Includes treatments that experts recommend for knee arthritis pain. These treatments can include pain relievers, structured exercise programs, weight management, or other non-invasive treatments such as acupuncture, yoga, and meditation.
2. Duloxetine: An oral medication that is used to improve pain and function in people with knee osteoarthritis.
3. Online Coping Skills Training: An online tool that teaches people skills such as relaxation, replacing negative thoughts, and problem-solving to decrease and manage pain.
If eligible for the study, the 1st phase will require:
- Completion of an online questionnaire
- Attending 3 study visits, which can be done either remotely or in person
Phase 2 Study Activities
Pre-Intervention Visit
In-person visit
- Insurance discussion
- Written consent procedures
- Pregnancy screening/toxicology
- Medication and medical history review
- Tramadol/opioid prescription provided (if indicated)
- Questionnaires
- Randomization into treatment arm
Baseline Visit
In-person visit
- Urine pregnancy and toxicology screening
(per clinic guidelines) - Questions about medication use
- Questionnaires
- Completion of randomized study procedure
4-Week and 12-Week Follow-Up
Call with a study team member (or in-person visit if needed)
- Survey
- Review of study medication
- How are you doing?
Post-Treatment Follow-Up Every
3 Months
Brief survey every 3 months
Phase 2 Treatments
People who participate in Phase 2 are randomized to one of three treatment groups:
1. Joint Injection: Hyaluronic acid is a normal part of the fluid that helps cushion your joint. This fluid becomes thinner when you have osteoarthritis. The steroid and bupivacaine help numb the joint and decrease swelling in the knee joint.
2. Nerve Block: A long-acting agent injected into 3 or more nerves in the knee to stop pain signals to the nervous system. Ultrasound or fluoroscopy (a type of X-ray) is used to help guide the injections into the nerves.
3. Nerve Ablation: Radio frequency waves that heat or cool the nerve to destroy the nerve signaling pain in the knee.
If interested in the 2nd phase of the study, there are:
- An additional 4 visits, some of which can also be done remotely if preferred
Follow-Up Assessments
People in the study will also complete brief follow-up assessments either online or on their phone so we can better understand how long these treatments are effective.
More information about the different treatments will be discussed after eligibility requirements have been met.
Why Is the SKOAP Study Important?
There is an urgent public health need to reduce our reliance on opioids for effective long-term pain management, particularly in Knee Osteoarthritis (KOA).
This effectiveness trial will compare recommended treatments to reduce pain and functional limitations in KOA and identify clinical and patient-level factors associated with treatment response.
These results will lead to improved patient selection for treatment and inform evidence-based guidelines by offering well-tested, effective, non-opioid alternatives.
How Can I Benefit From Participating in SKOAP?
Participating may reduce pain, improve knee function, and enhance quality of life without surgery
An opportunity to try different state-of-the-art treatments for knee pain
The opportunity to contribute to chronic pain research, which can help others with their condition
SKOAP participants may also earn up to $550 for completing study activities
Is the SKOAP Study Covered by Insurance?
Most insurance companies approve and cover our study procedures. There may be a copay that candidates will be responsible for.
That said, insurance coverage does vary by region and company. For specific questions, call the project coordinator at the closest SKOAP Study location using the contact information on the About Us page.
